Scientific Director, MS&T Compliance Systems

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The MS&T Compliance Systems Lead is responsible for overseeing the management and continuous improvement of compliance systems within Manufacturing Sciences & Technology (MS&T) with a primary focus on investigations escalation processes and Development and adoption of LLM documentation tools. This role ensures that all investigations are conducted in accordance with GxP requirements facilitates timely and effective escalation of critical issues and drives the adoption of advanced digital technologiesincluding Large Language Models (LLM)to enhance quality compliance and efficiency of MS&T documentation. The Compliance Systems Lead partners with cross-functional teams to implement best practices optimize workflows and support regulatory readiness across the organization.

The Director will be responsible for the governance implementation and lifecycle management of Large Language Models (LLMs) used in GxP-regulated environments (Good Laboratory Practice Good Clinical Practice Good Manufacturing Practice etc.). This role ensures that LLM solutions are developed validated deployed and maintained in compliance with regulatory requirements and internal quality standards. They will collaborate with cross-functional teams including IT Quality Regulatory Data Science and business stakeholders to drive the safe effective and compliant use of LLM technologies in support of business objectives.

This role will report to the Head of M&ST Systems and Engineering and will support the GBU manufacturing network both internal and external. The Director of MS&T Process Engineering will lead a team of experienced SMEs consisting of matrix reporting.

Key Responsibilities

1. Compliance Systems & Digital Tools

• Oversee and continuously improve MS&T compliance systems with emphasis on investigations escalation processes and the adoption of advanced digital tools (including LLMs).
• Lead the governance implementation and lifecycle management of LLMs in GxP-regulated environments ensuring compliance with regulatory requirements and internal quality standards.
• Oversee the end-to-end lifecycle of LLMs: selection development validation deployment monitoring and retirement.
• Monitor LLM performance manage incidents and drive continuous improvement initiatives.
• Ensure LLMs are implemented and maintained in compliance with GxP regulations company policies and industry best practices.
• Stay current with industry trends regulatory guidance and technological advancements related to AI/ML and LLMs in life sciences.

2. Investigations & Root Cause Analysis

• Lead and facilitate complex cross-functional investigations ensuring robust root cause analysis and effective corrective/preventive actions.
• Develop standardize and continuously improve investigation methodologies tools and templates for manufacturing deviations quality events and process issues.
• Identify trends and systemic issues from investigation data and recommend process improvements.
• Track and report investigation-related metrics (e.g. timeliness recurrence rates effectiveness of CAPA) to drive accountability and improvement.
• Serve as a subject matter expert in investigation techniques including data analysis interviewing and documentation.

3. Training Guidance & Stakeholder Engagement

• Design and deliver training programs for investigators and relevant staff fostering a culture of investigation excellence and knowledge sharing.
• Provide training and guidance to stakeholders on the compliant use of LLMs in GxP environments.
• Collaborate with IT Quality Regulatory and business teams to define and prioritize LLM use cases requirements and risk mitigation strategies.
• Liaise with site leadership to align on strategic needs and digital initiative priorities.
• Represent MS&T at key technical forums

4. Regulatory & Audit Support

• Support regulatory inspections and audits by providing investigation documentation and subject matter expertise.
• Develop and maintain documentation (requirements validation protocols risk assessments SOPs) to support regulatory inspections and audits.
• Lead or support validation and qualification activities for LLMs including change management and periodic review.
• Support audit and inspection readiness for LLM-related systems and processes.

5. Cross-functional Collaboration & Leadership

• Collaborate with manufacturing quality engineering and other stakeholders to ensure investigations are comprehensive and regulatory-aligned.
• Serve as the primary point of contact and subject matter expert for all LLM-related activities in GxP-regulated use cases

Qualifications & Experience

• Bachelors degree in a scientific engineering or related discipline; advanced degree preferred.
• Minimum 15 years of experience in pharmaceutical or biopharmaceutical manufacturing with significant experience in investigations and root cause analysis.
• Demonstrated expertise in leading complex investigations and developing investigation methodologies.
• Strong knowledge of cGMP regulatory requirements and quality systems.
• Experience in training and mentoring staff.
• Excellent analytical problem-solving and communication skills.
• Proficiency in investigation and data analysis tools/software.
• Ability to influence and collaborate across functions and levels of the organization
• Ability to anticipate industry trends and emerging issues
• Demonstrated ability to effectively develop and lead high performing global organizations of industry leading and highly talented experts
• Experience developing and implementing strategy to optimize processes and proactively manage risk
• Ability to develop and implement long term vision and strategy
• Ability to navigate complex matrix organisations

Why you should apply

• You will help patients in their fight against serious diseases
• You willbe part ofa company that encourages excellence and innovation respects diversity develops leaders and values its employees.
• Youll get a competitive salary and a great benefits package including but not only an annual bonus pension contribution family health insurance 27 days of annual leave access to BMS Cruiserath on-site gym and life assurance

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

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